Medical device recalls Moderate risk

Bausch & Lomb Inc recalls Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.

Recall date
August 8, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3265-2018
FDA classification
Class II
Brand / firm
Bausch & Lomb Inc
Sold / distributed
Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Swit…

Why it was recalled

The back cap separates from the body of the vitrectomy cutter.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.

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